A clinical study of Safety and Practicality of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) treatment for painful bone metastases
- Conditions
- metastatic bone tumor
- Registration Number
- JPRN-UMIN000030296
- Lead Sponsor
- Teikyo University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1) Patients with uncontrolled pain lesion except for targeted tumor. 2) More than 4 painful lesions. 3) Patients with NRS (0-10 scale) pain score <4 irrespective of medication. 4) No radiation therapy or chemotherapy in the past two weeks. 5) Patients with unstability of targeted tumor: -Pathological fracture -Need surgical stabilization in impending fracture. -Patients with surgical stabilization with metallic hard ware. 6) Patients on dialysis. 7) Patients with unstable cardiac status which interfere with daily life. -Unstable angina pectoris on medication. -Patients developed myocardial infarction within six months of protocol entry. -Congestive heart failure requiring medication (other than siuretic). -Any patients disqualified by a study physician because of their cardiac status. 8) Patients with severe hypertension (diastolic BP > 100 on medication). 9) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight > 113kilograms) and claustrophobia. 10) Known hypersensitivity to the MRI contrast agent (e.g. Magnevist etc.) including advanced kidney disease. 11) Karnofsky Performance Status < 60. 12) Severe cerebrovascular disease (multiple CVA or CVA within 6 months). 13) Individuals who are not able to tolerate prolonged stationary position during treatment (approximately 2 hrs). 14) Patients whose targeted tumor is less than 10-mm from nurve bundle, intestine or bladder. 15) Patients who are participating or have participated in another clinical trial in last 30 days. 16) Patients unable to communicate with the investigator and staff. 17) Pain source unidentifiable. 18) Patients who are pregnant or lactating. 19) Conspicuous prolong of coagulation time (limit to INR>1.5). 20) Any patients disqualified by a study physician or any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of pain score (Time Frame: within 6 months of treatment)
- Secondary Outcome Measures
Name Time Method Improvement in quality of life Changes in image findings of the treatment site (Time Frame: within 6 months of treatment)